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Audit / Compliance

USP has no governing authority, but most states have laws related to compounding which defer to USP 797 and usually fall under the state’s board of pharmacy. To date, we are not aware of any states that have given the authority to the pharmacy boards to inspect physicians offices, and at the national level the Federation of State Licensure Boards has opposed this concept.

If you mix allergy extracts for treament of patients in your office, you must follow USP 797. Personnel who only mix allergenic extracts must follow the guidelines laid out in chapter 21 of USP 797. Those who compound CSP 1 and CSP 2 formulations have stricter guidelines. Chapter 21 refers specifically to those who compound allergenic extracts.

Documentation

You should check with your state medical board– they should be part of your patient record rentention policy.

Facility

This question is addressed in USP 797 Chapter 21 paragraph 11, which states: “The impact of activities that will be conducted around or adjacent to the PEC or AECA must be considered carefully when designing such an area.” It also states: “During compounding activities, no other activity is permitted in the AECA.” We are concerned about the mixer being interrupted and distracted due to nearby activities in the same room as the AECA. This should be specifically addressed in your SOP.

This is not addressed in USP 797. but we would not recommend because of increased airborne particulates.

The window should be secured in a manner where there is not airflow from the outside into the room, nor able to be opened inadvertently.

This is not addressed in USP 797. The fans from HEPA air cleaners can actually increase local particulate counts. If used, they should have a CADR applicable to the size of the room.

In USP 797 Chapter 21 paragraph 7 there is no requirement to document room temperature or humidity. The requirements state “The AECA must be designed and controlled to provide a well-lighted working environment, with temperature and humidity controls for the comfort of compounding personnel wearing the required garb.”

Garbing

No, shoe covers are not a piece of the required garb detailed in Chapter 21 of USP 797 for compounding allergen extracts.

While the “no make-up” requirement is part of the general USP 797 standard, it is not included in the chapter 21 exception for compounding allergenic extracts. The requirements for Personnel Hygiene and Garbing under chapter 21 do not include the requirement to be cosmetic free.

Yes, low-lint, disposable covers for the head that cover the hair and ears; disposable cover for facial hair (if applicable) and a face mask.

USP 797 Chapter 21 paragraph 11 states: “Access to the AECA during compounding must be restricted to authorized personnel.” and “During compounding activities, no other activity is permitted in the AECA.” Non-mixers should not be in the AECA. The garb required for mixing, listed in USP 797 Chapter 21 paragraph 9, is required when actually mixing. They would not be required for non-mixing activities in the AECA.

Glove Sampling

The USP Standards stipulate the fingertip/thumb tests must be incubated at a temperature from 30-35 degrees celsius (86-95 degrees fahrenheit) for no less than 48 hours and then at 20-25 degrees celsius (68-77 degrees fahrenheit) for no less than five days. Invert plates to prevent condensate from dropping onto the agar, affecting the accuaracy of the CFU reading.

The College is working to develop resources regarding the gloved fingertip and thumb sampling test.

The requirement is somewhat confusing. Before being allowed to independently mix, the compounder must complete the test 3 separate times. That means the candidate must do a separate complete hand hygiene and garbing procedure before each test. After the initial evaluation, compounding personnel must successfully complete the gloved fingertip and thumb testing at least every 12 months.

Resources

Not currently, but we’re considering what resources to develop to assist our members.

Secondary Verification

This is not addressed in USP 797. Some mixing centers use a second person to verify that the amounts drawn up to be mixed into allergen extract vials are from the correct stock and drawn up in the right amounts. This is a safety check that ensures the correct antigen in the correct amount is being placed into the kit, but is not a USP 797 requirement.

Sterility

The keyboards should be cleaned along with the other areas. Personnel who are actively compounding should not be keying in at the same time.

70% IPA is used for sterilization. Vial stoppers on packages of conventionally manufactured sterile ingredients must be wiped with sterile 70% IPA and allowed to dry before being used for mixing. 70% IPA is also used for sterilization of gloves and work surfaces. USP 797 Chapter 21 Paragraph 10 states: “Compounding personnel must rub sterile 70% IPA onto all surfaces of the gloves and allow them to dry thoroughly throughout the compounding process.” and USP Chapter 21 Paragraph 12 states: “Apply sterile 70% IPA to the horizontal work surface between each prescription set.”

Per USP 797: *In an AECA, all work surfaces in the AECA where direct compounding is occurring must be cleaned and disinfected daily and when surface contamination is known or suspected. Apply sterile 70% IPA to the horizontal work surface between each prescription set. **If present, walls, doors, and door frames within the perimeter of the AECA must be cleaned and disinfected monthly and when surface contamination is know or suspected. ***Ceilings within the preimeter of the AECA must be cleaned and disinfected when visibly soiled and when surface contamination is known or suspected.

In an AECA, all work surfaces in the AECA where direct compounding is occurring must be cleaned and disinfected daily and when surface contamination is known or suspected. Apply sterile 70% IPA to the horizontal work surface between each prescription set.

YES. The USP Standards require: Personnel must wash hands and forearms up to the elbows with soap and water before initiating compounding activities. Brushes must not be used for hand hygeine. Hand dryers must not be used. A closed system of soap (i.e., non-refillable container) to minimize the risk of extrinsic contamination must be readily available or in close proximity to the sink. 1) Remove visible debris from underneath fingernails under warm running water using a disposable nail cleaner. 2) Wash hands and forearms up to the elbows with soap and water for at least 30 seconds. 3) Dry hands and forearms to the elbows completely with low-lint disposable towels or wipers. 4) Apply an alcohol-based hand rub to dry skin following the manufacturer’s instructions for the volume of product to use. 5) Apply poduct to one hand and rub hands together, covering all surfaces of hands and fingers, until hands are dry. 6) allow hands to dry thoroughly before donning sterile gloves. The actual type of soap or sanitizer is not delineated.

Stock Mix / Dilutions

USP 797 Chapter 21 Compounding Allergenic Extracts states that “Licensed allergenic extracts are mixed and diluted into prescription sets for an individual patient, even though these allergenic extract combinations are not specified in the approval licenses for the licensed biological products.” This was an important reason the USP Expert Committee allowed variations from the overall rule. Also, the 2010 Allergen immunotherapy: A practice parameter third update states that the mixing of antigens in a syringe is not recommended because of the potential for treatment errors and cross-contamination of extracts.

Storage

Yes. USP 797 Chapter 21 Paragraph 16 states the label of each vial of an allergenic extract prescription set must display prominently and understandably the storage conditions for the extract.

Supervision

USP 797 chapter 21 for Compounding Allergenic Extracts states that ” A designated person with training and expertise in allergen immunotherapy is responsible for ensuring that personnel who will be preparing allergen immunotherapy are trained, evaluated, and supervised.” If you are that “Designated Person” you should take the test. Otherwise it is not required, but may be helpful if your staff were to have questions about points addressed in the test.

Transfer

Per USP 797: *If shipping or transporting allergenic extract prescription sets, compounding personnel must select modes of transport that are expected to deliver properly packed prescription sets in an undamaged, sterile and stable condition. Inappropriate transport can adversely affect the quality of allergenic extract prescription sets. **When shipping or transporting allergenic extract prescription sets that require special handling, personnel must include specific handling instruction on the exterior of the container.

Per USP 797: *If shipping or transporting allergenic extract prescription sets, compounding personnel must select modes of transport that are expected to deliver properly packed prescription sets in an undamaged, sterile and stable condition. Inappropriate transport can adversely affect the quality of allergenic extract prescription sets. **When shipping or transporting allergenic extract prescription sets that require special handling, personnel must include specific handling instruction on the exterior of the container.

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